Table 3.
Summary of Naltrexone (NTX) Efficacy and Safety in Adult Trials for Alcohol Use
| Reference | Sample Size (Study Design) | Drug Dosing and Duration | Outcomes |
|---|---|---|---|
| Volpicelli135 | 70 (PCT) | NTX: 50 mg/day for 12 wk | Craving score: NTX: 1.41; PLB: 3.42 SAE: none |
| Oslin136 | 221 (PCT, genotype controlled for variant rs1799971) | NTX: 50 mg/day for 12 wk | Heavy drinking OR: Wildtype: 0.69 (95% CI: 0.41–1.18); Variant: 1.10 (95% CI: 0.52–2.31) SAE: none |
| O’Malley137 | 97 (PCT) | NTX: 50 mg/day plus supportive therapy or coping skills therapy for 12 wk | Abstinence rate (supportive group): NTX: 61%; PLB: 19% SAE: none |
| Anton138 | 1383 (PCT) | NTX: 100 mg/day for 16 wk ± medical management | Days abstinent: NTX: 80% (CV = 33%); PLB: 74% Good clinical outcome (medical management group): NTX: 74%, PLB 58%; NNT: NTX (n = 6) SAE: One possibly related to NTX (not further described) |
| Garbutt139 | 624 (PCT) | XR-NTX: 190 mg or 380 mg IM monthly for 6 mo | Heavy drinking days (relative to PLB): High dose: −25%; Low dose: −17% SAE: NTX group (eosinophilic pneumonia, interstitial pneumonia) |
| Kranzler140 | 315 (PCT) | XR-NTX: IM monthly for 3 mo | Absence of heavy drinking: NTX: 23%, PLB: 16% Abstinence rate: NTX: 18%, PLB: 10% SAE: none |
CV, coefficient of variation; IM, intramuscular; NNT, numbers needed to treat; PCT, placebo-controlled trial; PLB, placebo; PO, orally; SAE, severe adverse effect